Two-Hour Session Will Feature Two Live Cases; Pooled Analysis of Bifurcation Stent System Will Examine Evidence from Eight Clinical Studies
DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to
definitively treat bifurcation lesions, today announced activities
highlighting the latest experience with the TRYTON Side Branch Stent at
EuroPCR, the official congress of the European Association of
Percutaneous Cardiovascular Interventions, taking place at the Palais
des Congrès May 15-18, 2012 in Paris.
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On Wednesday, May 16 from 2:00 p.m. to 4:00 p.m. in the Theatre
Bordeaux, William Wijns, M.D., and Martin B. Leon, M.D., will chair a
“Tools and Techniques” session featuring two live transmissions of
patients treated using the Tryton stent by Eulogio Garcia, M.D., of
the Hospital Clinico San Carlos in Madrid, Spain. -
On Thursday, May 17, at 11:22 a.m. in Room 341, Maik Grundeken, M.D.,
of the Department of Cardiology at the University of Amsterdam in the
Netherlands, will present a patient-level pooled analysis of six-month
clinical outcomes from more than 900 patients treated with the Tryton
stent in eight post-marketing registries. -
In addition, the conference will feature more than 10 Tryton case
reports and three abstracts presenting data related to the Tryton
stent system.
The Tryton stent has now been used to treat approximately 5,000 patients
and is commercially available throughout Europe, Russia and the Middle
East. The company recently began enrollment in the first and only
randomized controlled U.S. IDE pivotal clinical trial evaluating a
dedicated bifurcation stent. The 704-patient study compares a Tryton
stent in the side branch vs. the use of balloon angioplasty in the side
branch, with both arms of the trial utilizing a standard drug eluting
stent in the main vessel. The trial has completed its IVUS angiographic
sub study cohorts and enrollment remains on schedule to complete
enrolllment later this year. The results of the trial will be submitted
to the U.S. Food and Drug Administration (FDA) for approval to market
the device in the United States.
Clinical data presented on more than 1,000 patients treated with the
Tryton stent has demonstrated consistent target lesion revascularization
rates of less than four percent and low thrombosis rates at six-month
follow up and beyond.
About Coronary Bifurcation Disease
Coronary artery disease often results in the buildup of plaque at the
site of a bifurcation, where one artery branches from another. Current
approaches to treating these lesions are time consuming and technically
difficult. As a result, the side branch is often left unstented, leaving
it vulnerable to higher rates of restenosis, the re-narrowing of the
stented vessel following implantation.1 In patients
undergoing PCI-stenting, approximately one-third have a bifurcation
lesion. Left main disease, an accumulation of plaque that narrows the
base of the coronary tree, is a persistent challenge in interventional
cardiology, as more than 75 percent of left main lesions are bifurcation
lesions.
About the Tryton Side Branch Stent
The Tryton Side Branch Stent System is built for bifurcation using
proprietary Tri-zone™ technology to offer a dedicated strategy for
treating bifurcation lesions. Tryton’s cobalt chromium stent is deployed
in the side branch artery using a standard single-wire
balloon-expandable stent delivery system. A conventional drug-eluting
stent is then placed in the main vessel. The stent system has received
CE Mark and is commercially available throughout Europe, Russia and the
Middle East. It is approved in the United States for investigational use
only.
About the Randomized Tryton IDE Pivotal Study
The landmark Tryton pivotal study is a multi-national randomized trial
that compares a Tryton stent in the side branch vs. the use of balloon
angioplasty in the side branch, with both arms of the trial utilizing a
standard drug eluting stent in the main vessel. The study, which is the
first and only randomized IDE pivotal clinical trial evaluating a
dedicated bifurcation stent, will enroll 704 patients at up to 75
centers in North America, Europe and Israel. Martin Leon, M.D. (Columbia
University, New York) serves as principal investigator for the study and
Patrick Serruys (Thoraxcenter, Rotterdam) is leading IVUS and
three-dimensional angiographic analysis.
About Tryton Medical, Inc.
Tryton Medical, Inc., located in Durham, N.C., is a leading developer of
novel stent systems for the treatment of bifurcation lesions. The
company was founded in 2003 by Aaron V. Kaplan, M.D. (professor of
medicine at Dartmouth Medical School/Dartmouth- Hitchcock Medical
Center) and Dan Cole to develop stents for the definitive treatment of
bifurcation lesions. Privately held, Tryton is backed by Arnerich
Massena & Associates, Spray Ventures, PTV Sciences, and RiverVest
Ventures. For more information please visit trytonmedical.com.
Tryton Medical, Inc.
Nicole Osmer, 650-454-0504
nicole@nicoleosmer.com